Recalls / —
—#183728
Product
Quick Release Gait Belt, 60
- FDA product code
- IKX — Aid, Transfer
- Device class
- Class 1
- Medical specialty
- Physical Medicine
- Affected lot / code info
- Model: MDT821208NATM /503689 Lots: 33019040001, 33019090001 and 33019100001 Used in kits with model number: DYKF1045 Lots: 20EBB832 and 20EBM643.
Why it was recalled
The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
Root cause (FDA determination)
Process design
Action the firm took
On Sep 15 2020 the firm sent an notification to its customers via email, with the following instructions: REQUIRED ACTION: 1. Immediately check your stock for the specific kit number and the affected kit lot number in the attached list. Quarantine any kits with the listed lot numbers. If you dont have any of the lots listed above skip to step 3. 2. Remove affected Gait Belts prior to use of the Fall Prevention Kit. Please be sure NOT to use the recalled Gait Belts and return those to Medline. Medline will supply replacement belts at no charge to you. 3. Please return the completed enclosed verification form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, via email as indicated on the verification form. 4. Return the enclosed Verification Form via email to recalls@medline.com or fax 866-767-1290. 5. If you are a distributor, promptly notify any of your customers that may have received affected product. Note: By signing and returning the Verification Form, you acknowledge that you received and understand this notification.
Recalling firm
- Firm
- Medline Industries Inc
- Address
- 3 Lakes Dr, Northfield, Illinois 60093-2753
Distribution
- Distribution pattern
- Domestic Distribution Only: IL, MI
Timeline
- Recall initiated
- 2020-09-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #183728. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.